Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 29049 |
| Brand Name: | ExacTrac Body Patient Positioning System |
| Model: | |
| Affected: | |
| Software version: | 1.0.0, 1.0.1, 1.0.2, 1.0.3 |
| Recalling Organisation: | Avania Pty Ltd Level 2 142 Broadway Newmarket Auckland 1023 |
| Contact Information: | |
| Manufacturer: | Brainlab SE |
| Issue: | The manufacturer has determined that calculation of the yaw angle of the CBCT offset may be wrong under the following combined conditions · A setup beam is loaded on the Varian LINAC during the calculation of the CBCT offset at the CBCT X-ray Reference Acquisition step of the ETD workflow. · The internal parameters original planned Patient Support Angle (PSA) and updated planned Patient Support Angle (PSA) have different values at this CBCT X-ray Reference Acquisition step. As a consequence, for all subsequent patient repositioning(s) performed using ETD, there will be a deviation from the patient's intended position for the yaw value. Additionally, the offset error might be propagated to the ETD surface tracking, and therefore may adversely affect the surface monitoring ( ie indicators, related warnings, and beam hold functionality). |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 2/3/2022 |
